中医药治疗慢性肾小球肾炎临床疗效的Meta分析
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摘要
目的：通过对中医或中西医结合治疗慢性肾小球肾炎(CGN)的临床试验进行Meta分析,评价中医药及不同中医治法治疗CGN的疗效,得出相对可靠的目前中医药治疗CGN疗效的循证医学证据。
方法：采用计算机和手工检索,收集所有符合纳入标准的临床随机对照试验(RCT)及临床对照试验(CCT)文献,对每个研究进行质量评价、数据信息提取,采用Cochrane协作网提供的Revman4.2软件进行综合分析处理,得出结论。
结果：共纳入19项试验,1898例患者,分为治疗组与对照组,治疗组采用单纯中医药治疗或联合西医治疗措施,对照组单用西医治疗。对其中4项理化指标(24小时尿蛋白定量、尿红细胞、血尿素氮、血肌酐)进行观察。Meta分析结果显示：①中医或中西医结合治疗对CGN临床疗效优于西医治疗；②中医或中西医结合治疗对24小时尿蛋白定量的疗效优于西医治疗；③中医或中西医结合治疗对尿红细胞的疗效优于西医治疗；④中医或中西医结合治疗与西医治疗对血尿素氮的疗效无明显差异,不能认为中医或中西医结合治疗对血尿素氮的疗效优于西医治疗；⑤中医或中西医结合治疗与西医治疗对血肌酐的疗效无明显差异,不能认为中医或中西医结合治疗的疗效优于西医治疗；⑥中药或联合ACEI治疗对24小时尿蛋白定量的疗效优于单用ACEI;⑦益肾清利法对24小时尿蛋白定量的疗效优于西医治疗；⑧其他中医治法(如活血化瘀、清热利湿、益气养阴等)对24小时尿蛋白定量的疗效优于西医治疗；⑨本研究纳入试验可能存在一定发表偏倚；⑩无论是单纯中药或中西医结合治疗,其安全性相对较高,不良反应发生少。
结论：中医或中西医结合治疗CGN的临床疗效优于西医治疗,中药或联合ACEI对蛋白尿的治疗作用优于单用ACEI,益肾清利法及其他中医治法对蛋白尿的治疗作用优于单纯西医治疗,提示中医药较之单纯西医治疗有较好的控制蛋白尿和血尿的作用。但由于本研究纳入试验数量有限且存在方法学上的缺陷,致使Meta分析结果的证据强度不高,今后有必要进行高质量的多中心、随机、盲法、对照试验进一步证实。
Objective:To utilize the Meta-analysis method in clinic trials from documents of TCM treatment, also of Chinese and Western combined medicine on CGN, thus those therapeutic effect could be evaluated. Therefore, this study can give a clue to the relatively reliable TCM regimen in the evidence-based medicine.
Method:By computer and manual search, collecting all the RCT and CCT documents which comply with the inclusion criteria. In each study, evaluating their qualities and extracting their data. Then, this study processes them comprehensively with the Revman4.2 software provided by the Cochrane collaboration before the conclusion.
Results:a total of 19 tests,1898 patients are included, divided into the treatment group and control group. The treatment group takes pure TCM therapy or a combination of traditional Chinese and western medicine. The control group takes western medicine measures only. On which four physiochemical indices (24-hour urinary protein quantitative, urinary red blood cells, blood urea nitrogen, and blood creatinine) were observed. Meta-analysis results show that:①TCM or combining traditional Chinese and western medicine treatment on CGN enjoys a clinically superior effect compared with western medicine;② On the 24-hour urine protein quantitative aspect, TCM or combining traditional Chinese and western medicine treatment has a better therapeutic effect;③On reducing the urinary red blood cells, TCM or combining traditional Chinese and western medicine treatment has a better therapeutic effect;④For the blood urea nitrogen, TCM or combining traditional Chinese and western medicine treatment show no obvious difference with the western medicine. This fact cannot indicate a better curative result of TCM or combining traditional Chinese and western medicine treatment.⑤For the blood creatinine, TCM or combining traditional Chinese and western medicine treatment show no obvious difference with the western medicine. This fact cannot indicate a better curative result of TCM or combining traditional Chinese and western medicine treatment.⑥TCM or ACEI combined treatment improves the 24-hour urine protein quantitative better than using ACEI alone;⑦The therapeutic method of tonifying the kidney and clearing rip hath improves the 24-hour urine protein quantitative better than the western medicine;⑧Other TCM therapeutic method (such as promoting blood circulation and removing blood stasis, clearing heat and promoting diuresis, tonifying qi and yin.etc.) improve the 24-hour urine protein quantitative better than the western medicine;⑨The inclusion trials in this study may exist certain publication bias;⑩Either TCM or combining traditional Chinese and western medicine treatment has a higher safety rate and has rare adverse reactions.
Conclusion:TCM or combining traditional Chinese and western medicine treatment on CGN enjoys a clinically superior effect compared with western medicine. TCM or ACEI combined treatment improves the 24-hour urine protein quantitative better than using ACEI alone; TCM therapeutic methods including tonifying the kidney and clearing rip hath method improve the 24-hour urine protein quantitative better than the western medicine, this indicates that TCM has advantage in treating proteinuria and hematuria. However, because of the on limita-tion included trial numbers and defects on methodology, the Meta-analysis conclusions may be not that convincing enough. Multicenter, randomized, blinding and controlled trials in high quality need to be carried out for further confirmed study.
方法：采用计算机和手工检索,收集所有符合纳入标准的临床随机对照试验(RCT)及临床对照试验(CCT)文献,对每个研究进行质量评价、数据信息提取,采用Cochrane协作网提供的Revman4.2软件进行综合分析处理,得出结论。
结果：共纳入19项试验,1898例患者,分为治疗组与对照组,治疗组采用单纯中医药治疗或联合西医治疗措施,对照组单用西医治疗。对其中4项理化指标(24小时尿蛋白定量、尿红细胞、血尿素氮、血肌酐)进行观察。Meta分析结果显示：①中医或中西医结合治疗对CGN临床疗效优于西医治疗；②中医或中西医结合治疗对24小时尿蛋白定量的疗效优于西医治疗；③中医或中西医结合治疗对尿红细胞的疗效优于西医治疗；④中医或中西医结合治疗与西医治疗对血尿素氮的疗效无明显差异,不能认为中医或中西医结合治疗对血尿素氮的疗效优于西医治疗；⑤中医或中西医结合治疗与西医治疗对血肌酐的疗效无明显差异,不能认为中医或中西医结合治疗的疗效优于西医治疗；⑥中药或联合ACEI治疗对24小时尿蛋白定量的疗效优于单用ACEI;⑦益肾清利法对24小时尿蛋白定量的疗效优于西医治疗；⑧其他中医治法(如活血化瘀、清热利湿、益气养阴等)对24小时尿蛋白定量的疗效优于西医治疗；⑨本研究纳入试验可能存在一定发表偏倚；⑩无论是单纯中药或中西医结合治疗,其安全性相对较高,不良反应发生少。
结论：中医或中西医结合治疗CGN的临床疗效优于西医治疗,中药或联合ACEI对蛋白尿的治疗作用优于单用ACEI,益肾清利法及其他中医治法对蛋白尿的治疗作用优于单纯西医治疗,提示中医药较之单纯西医治疗有较好的控制蛋白尿和血尿的作用。但由于本研究纳入试验数量有限且存在方法学上的缺陷,致使Meta分析结果的证据强度不高,今后有必要进行高质量的多中心、随机、盲法、对照试验进一步证实。
Objective:To utilize the Meta-analysis method in clinic trials from documents of TCM treatment, also of Chinese and Western combined medicine on CGN, thus those therapeutic effect could be evaluated. Therefore, this study can give a clue to the relatively reliable TCM regimen in the evidence-based medicine.
Method:By computer and manual search, collecting all the RCT and CCT documents which comply with the inclusion criteria. In each study, evaluating their qualities and extracting their data. Then, this study processes them comprehensively with the Revman4.2 software provided by the Cochrane collaboration before the conclusion.
Results:a total of 19 tests,1898 patients are included, divided into the treatment group and control group. The treatment group takes pure TCM therapy or a combination of traditional Chinese and western medicine. The control group takes western medicine measures only. On which four physiochemical indices (24-hour urinary protein quantitative, urinary red blood cells, blood urea nitrogen, and blood creatinine) were observed. Meta-analysis results show that:①TCM or combining traditional Chinese and western medicine treatment on CGN enjoys a clinically superior effect compared with western medicine;② On the 24-hour urine protein quantitative aspect, TCM or combining traditional Chinese and western medicine treatment has a better therapeutic effect;③On reducing the urinary red blood cells, TCM or combining traditional Chinese and western medicine treatment has a better therapeutic effect;④For the blood urea nitrogen, TCM or combining traditional Chinese and western medicine treatment show no obvious difference with the western medicine. This fact cannot indicate a better curative result of TCM or combining traditional Chinese and western medicine treatment.⑤For the blood creatinine, TCM or combining traditional Chinese and western medicine treatment show no obvious difference with the western medicine. This fact cannot indicate a better curative result of TCM or combining traditional Chinese and western medicine treatment.⑥TCM or ACEI combined treatment improves the 24-hour urine protein quantitative better than using ACEI alone;⑦The therapeutic method of tonifying the kidney and clearing rip hath improves the 24-hour urine protein quantitative better than the western medicine;⑧Other TCM therapeutic method (such as promoting blood circulation and removing blood stasis, clearing heat and promoting diuresis, tonifying qi and yin.etc.) improve the 24-hour urine protein quantitative better than the western medicine;⑨The inclusion trials in this study may exist certain publication bias;⑩Either TCM or combining traditional Chinese and western medicine treatment has a higher safety rate and has rare adverse reactions.
Conclusion:TCM or combining traditional Chinese and western medicine treatment on CGN enjoys a clinically superior effect compared with western medicine. TCM or ACEI combined treatment improves the 24-hour urine protein quantitative better than using ACEI alone; TCM therapeutic methods including tonifying the kidney and clearing rip hath method improve the 24-hour urine protein quantitative better than the western medicine, this indicates that TCM has advantage in treating proteinuria and hematuria. However, because of the on limita-tion included trial numbers and defects on methodology, the Meta-analysis conclusions may be not that convincing enough. Multicenter, randomized, blinding and controlled trials in high quality need to be carried out for further confirmed study.
引文
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